Aerobic Exercise and Cognitive Training in Patients With Stroke

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Treatments: Behavioral: Pedaling as a moderate intensity aerobic exercise; Biological: BDNF evaluation; Diagnostic Test: VO2 assessment; Other: Cognitive Training; Behavioral: Neuropsychological evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05735405

Version 1 01/09/22;

Details and patient eligibility

About

The goal of this clinical trial is to test the effects of aerobic exercise and BDNF on patients with ischemic and hemorrhagic stroke during a computerized cognitive training.

The main questions it aims to answer are:

1. Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
2. Is it possible to exploit the timing of rehabilitation interventions to obtain greater effects? Participants will be divided in 2 groups. The experimental group will first perform 20 minutes of pedaling as a moderate intensity aerobic exercise. It will then participate in one-hour cognitive training sessions, with the aim of training attentional, working memory and executive functions. The control group will carry out the same interventions but in reverse order.

The researchers will compare the results of the cognitive training in the two groups to verify if the order of the interventions influences the results themselves.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a clinical diagnosis of stroke, both ischemic and haemorrhagic.
• Patients admitted to the Specialist Rehabilitation Unit 1 of the "E. Spalenza - Don Gnocchi "of Rovato.
• Overall score in the MoCA test ³ 26
• In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with score in the norm, P.E. > 1
• Hypertonic and spasticity picture compatible with the performance of motor activity of pedaling expected in the EA session.
• Tolerance of physical exercise
• Incoming electrocardiogram normal and free of anomalies

Exclusion criteria

• Overall score in the MoCA test <26
• In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with pathological or borderline score, P.E. £ 1.
• Documented diagnosis of neurodegenerative diseases with impact on performance cognitive.
• Severe acquired brain injury
• Illiteracy
• Status of hypertonus and spasticity not compatible with the performance of motor training
• Excessive fatigue: the patient does not tolerate moderate intensity physical activity and accuses excessive fatigue during the preliminary test
• Electrocardiogram at entrance with anomalies and / or altered
• Ischemic heart disease
• Cardiac disorders that are contraindications for aerobic activity of moderate intensity

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental Group

Experimental group

Description:

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Treatment:

Biological: BDNF evaluation

Diagnostic Test: VO2 assessment

Behavioral: Neuropsychological evaluation

Other: Cognitive Training

Behavioral: Pedaling as a moderate intensity aerobic exercise

Control Group

Experimental group

Description:

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Treatment:

Biological: BDNF evaluation

Diagnostic Test: VO2 assessment

Behavioral: Neuropsychological evaluation

Other: Cognitive Training

Behavioral: Pedaling as a moderate intensity aerobic exercise